Dong-A ST announced on the 5th that Accord Biopharma, a subsidiary of Intas Pharmaceuticals, has completed Biologics License Application (BLA) for Stelara biosimilar ‘DMB-3115’ to the U.S. Food and Drug Administration (FDA). The BLA, originally submitted in October 2023, has now been approved by the FDA.

The BLA submission was based on the results from quality equivalence testing between Stelara and DMB-3115 conducted in both the United States and Europe. The global Phase 3 clinical trials enrolled patients with moderate to severe chronic plaque psoriasis, and the result demonstrated therapeutic equivalence between DMB-3115 and Stelara. There were no clinically significant differences in safet